Induction Chemotherapy With TP+5-FU or TP+Cetuximab Followed by Radioimmuptherapy for Locally Advanced or Not Resectable SCCHNN
HNO-2
Randomised Phase II Pilot Study: Induction Chemotherapy With Docetaxel, Cisplatin and Cetuximab Versus Docetaxel, Cisplatin and 5 FU Followed by Radiotherapy With Cetuximab for Locally Advanced or Not Resectable Carcinoma of the Head and Neck
1 other identifier
interventional
100
1 country
8
Brief Summary
This multicentre, randomised Phase II Pilot Study evaluates the efficacy of docetaxel, cisplatin and 5-fluorouracil or Cetuximab, followed by Cetuximab with radiotherapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2013
Longer than P75 for phase_2
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 18, 2012
CompletedStudy Start
First participant enrolled
May 1, 2013
CompletedFirst Posted
Study publicly available on registry
June 24, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 28, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 13, 2022
CompletedMay 26, 2022
May 1, 2022
7.8 years
May 18, 2012
May 20, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Response Rate (CR, PR)
RECIST criteria
3 months after end of therapy
Secondary Outcomes (5)
Overall Response Rate (CR, PR, PD, SD)
until 3 months after therapy
Locoregionally monitoring
after one year
Progression Free Survival (PFS)
1, 2 and 5 years after start of therapy
Adverse reactions
During treatment and until 60 months after end of radiotherapy
Overall-Survival
1, 2 and 5 years after start of therapy
Study Arms (2)
A
ACTIVE COMPARATORPatients receive 3 cycles (cycle duration 21 days) of docetaxel (75mg/m²), cisplatin (75mg/m²) and 5-fluorouracil (750mg/m²) followed by Cetuximab (weekly, starting with 400mg/m² then continuing with 250 mg/m²) with radiotherapy (concomitant boost for 6 weeks). Active comparator is 5-fluorouracil for first three cycles.
B
EXPERIMENTALAll patients receive 3 cycles (cycle duration 21 days) of docetaxel (75mg/m²), cisplatin (75mg/m²) Cetuximab (weekly, starting with 400mg/m² and continuing with 250 mg/m²), followed by Cetuximab (weekly 250 mg/m²) with radiotherapy (concomitant boost for 6 weeks). Experimental: cetuximab for the first three cycles.
Interventions
weekly, starting with 400 mg/m² during 120 min.(saturation) then continuing with 250 mg/m²; duration 3 cycles with 21 days
weekly, starting with 400 mg/m² during 120 min.(saturation only arm A) then continuing with 250 mg/m²; duration 7 weeks
First 18 irradiations once daily with single dose of 1,8 Gy for 5 days per week. In addition by day 19 a second irradiation boost will be applied for further 12 days(1,5 Gy per day with at least 5 hours interval to 1,8 Gy dose. This results in total clinical target dose of 72 Gy and total subclinical target dose of 54 Gy. Duration of irradiation: 6 weeks
Eligibility Criteria
You may qualify if:
- Histologically confirmed local advanced squamous cell carcinoma of the Larynx, Hypopharynx, Oropharynx or Cavum oris stage III and IV
- One measureable lesion (CT oder MR)
- Age 18 - 75 (including)
- Performance Score ECOG 0 - 1
You may not qualify if:
- Distant metastases
- ECOG Score \>1
- Prior radiation (Head and neck area)
- Creatinin Clearance below 60 ml/µl
- Acute infections
- Neuropathy grade 3 or 4
- Myocardial Infarction within the last 12 months
- Acute coronary syndrome or othe clinically significant cardiovascular diseases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Landeskrankenhaus Feldkirch
Feldkirch, A-6807, Austria
Landesklinikum Krems
Krems, A-3500, Austria
Krankenhaus d. Barmherzigen Schwestern Linz
Linz, A-4010, Austria
Kepler Universitätsklinikum, Med Campus III. Klinik für Interne 3 - Schwerpunkt Hämatologie u. Onkologie
Linz, A-4021, Austria
PMU Salzburg
Salzburg, 5020, Austria
Hanusch Krankenhaus Wien
Vienna, 1140, Austria
Universität f. Strahlentherape, AKH Wien
Vienna, A-1090, Austria
Klinikum Kreuzschwestern Wels GmbH
Wels, A-4600, Austria
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Felix Keil, Prof.Dr.
Hanuschkrankenhaus
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 18, 2012
First Posted
June 24, 2013
Study Start
May 1, 2013
Primary Completion
January 28, 2021
Study Completion
January 13, 2022
Last Updated
May 26, 2022
Record last verified: 2022-05